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Home > "C" Clinical Trials Conditions > Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Persistent Ovarian Epithelial Cancer  Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Persistent Ovarian Epithelial Cancer
Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Persistent Ovarian Epithelial Cancer
For Condition: ovarian serous cystadenocarcinoma,ovarian endometrioid adenocarcinoma,Brenner Tumor,ovarian undifferentiated adenocarcinoma,recurrent ovarian epithelial cancer,stage 3 ovarian epithelial cancer,ovarian mixed epithelial carcinoma,ovarian clear cell cystadenocarcinoma,ovarian mucinous cystadenocarcinoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Eastern Cooperative Oncology Group,Southwest Oncology Group,Cancer and Leukemia Group B,Gynecologic Oncology Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. It is not yet known whether chemotherapy alone is more effective than chemotherapy plus peripheral stem cell transplantation for ovarian epithelial cancer . PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel and carboplatin with that of carboplatin, mitoxantrone, and cyclophosphamide followed by peripheral stem cell transplantation in treating patients who have persistent stage III or stage IV ovarian epithelial cancer.
Details: OBJECTIVES: I. Compare progression-free and overall survival after salvage therapy with standard-dose paclitaxel/carboplatin vs. high-dose carboplatin/mitoxantrone/cyclophosphamide followed by bone marrow reconstitution in drug-sensitive, low-volume ovarian cancer that is persistent following standard therapy. II. Compare the toxic effects of these two salvage regimens. III. Compare selected health-related aspects of quality of life in these patients. PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by participating institution and disease state at reassessment laparotomy. Patients are assigned to one of two treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours on day 1 and carboplatin as a continuous infusion on days 1-5 every 3 weeks for a total of 6 courses. Arm II: Patients receive cyclophosphamide IV over 1 hour and mitoxantrone over 15 minutes on days -8, -6, and -4, and carboplatin by continuous infusion on days -8 through -4, followed by rescue with autologous bone marrow or peripheral blood stem cells on day 0. Patients in both groups complete quality-of-life surveys just prior to randomization, at 3 weeks and 9 weeks after starting treatment, and every 3 months for an additional 5 assessments regardless of disease progression. PROJECTED ACCRUAL: A total of 275 patients will be accrued over approximately 60 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /65 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed stage III or IV epithelial ovarian carcinoma including the following cellular diagnoses: Serous adenocarcinoma; Mucinous adenocarcinoma; Endometrioid adenocarcinoma; Clear cell adenocarcinoma; Undifferentiated carcinoma; Mixed epithelial carcinoma; Transitional cell carcinoma; Malignant Brenner's Tumor - Stage III (optimal or suboptimal) must be surgically reassessed or Stage III (suboptimal) or Stage IV clinically reassessed after induction chemotherapy - For Stage III surgical reassessment: No more than 12 weeks between end of chemotherapy and reassessment surgery AND No more than 6 weeks between reassessment surgery and randomization - Patients treated on protocol GOG-158 are eligible - At least a partial response to chemotherapy as defined as: Microscopic disease documented at reassessment surgery for patients optimally debulked (disease no greater than 1 cm) after primary surgery - Suboptimally debulked disease (greater than 1 cm) after primary surgery and either: Negative reassessment laparotomy, Only microscopic disease at reassessment surgery, OR Gross residual disease no greater than 1 cm at reassessment surgery prior to debulking - Clinical complete response to induction chemotherapy including: suboptimal disease Stage III or IV AND either an abnormal CT or elevated CA-125 prior to induction chemotherapy and both are within normal limits following induction chemotherapy --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: At least 4 and no more than 6 prior platinum-based combination chemotherapy regimens (i.e., cisplatin or carboplatin) required; See Disease Characteristics - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: See Disease Characteristics - Other: No prior anthracyclines --Patient Characteristics-- - Age: Under 66 - Performance status: GOG 0 or 1 - Hematopoietic: Absolute granulocyte count at least 1,000/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; AST no greater than 3 times normal - Renal: Creatinine clearance at least 60 mL/min - Cardiovascular: Left ventricular ejection fraction at least 45% by MUGA; No congestive heart failure - Pulmonary: FEV1 and FVC at least 60% - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No prior malignancy in the past 5 years except adequately treated nonmelanomatous skin cancer, carcinoma in situ of the cervix, or any other cancer whose prior treatment does not contraindicate this study; Agreement with third party payer for coverage required
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertPark, Study Chair, Gynecologic Oncology Group
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104
United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38163
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
Veterans Affairs Medical Center - Togus
Togus, Maine, 04330
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128
United States
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
University of Illinois at Chicago Health Sciences Center
Chicago, Illinois, 60612
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102-1192
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13210
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston Salem, North Carolina, 27157-1082
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Veterans Affairs Medical Center - Chicago (Lakeside)
Chicago, Illinois, 60611
United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, 54449
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
New England Medical Center Hospital
Boston, Massachusetts, 02111
United States
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, 35233
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
Vanderbilt Cancer Center
Nashville, Tennessee, 37232-6838
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, 37212
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000064983; GOG-164
Study Start Date: November 1996
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002819
Other Ovarian Mucinous Cystadenocarcinoma Studies:
1. Paclitaxel Plus Carboplatin With or Without SCH-58500 in Treating Patients With Newly Diagnosed Stage III Ovarian or Stage III Primary Peritoneal Cancer
2. Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
3. Melphalan and Thiotepa Followed by Peripheral Stem Cell Transplantation in Treating Patients With Epithelial Ovarian Cancer in Complete Remission
4. Combination Chemotherapy Plus IM-862 in Treating Patients With Resected Stage III Ovarian Cancer or Primary Peritoneal Cancer
5. Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Persistent Ovarian Epithelial Cancer
Related Studies:
Other ovarian mucinous cystadenocarcinoma Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Persistent Ovarian Epithelial Cancer
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